| | | | | | | | | | |
|
|
| Dockets Entered
On October 10, 2003
Table of Contents
|
|
|
|
|
|
|
| Docket #
|
| Title
|
|
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness;Registration of Food Facilities
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| 2003M-0443
|
| Premarket Approval, BP 010009/0, Cambridge Biotech HIV-1 Urine Western Blot
|
|
|
| 2003M-0444
|
| Premarket Approval, BP 010001/0, NucliSens HIV-1 QT
|
|
|
| 2003M-0445
|
| Premarket Approval, BP 000028/0, The VERSANT HIV-1 RNA 3.0 Assay (bDNA)
|
|
|
| 2003M-0446
|
| Premarket Approval, BP 010047/0, OraQuick Rapid HIV-1 Antibody Test
|
|
|
| 2003M-0447
|
| Premarket Approval, BP-020066/0, Vironstika HIV-1 Plus O Microelisa System
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| 2003N-0467
|
| Risk Assessment for Food Terrorism and Other Food Safety Concerns; Availability
|
|
|
| 2003P-0475
|
| Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
|
|
|
| 2003P-0477
|
| Expedite the revocation of determination of the application of the AIP
|
|
|
| 2003V-0473
|
| Variance Laser Display Device, JENOPTIK LOS: JenLas WHiteLight; Projector
|
|
|
| 1997S-0162
|
| 30-Day Structure Function Claim Notification Letters Dietary
|
|
|
| LET
11242
|
| Wellness International Network, Ltd.
|
| Vol #:
|
| 85
|
|
|
| LET
11243
|
| Enzymatic Therapy Natural Medicines
|
| Vol #:
|
| 85
|
|
|
| LET
11244
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11245
|
| Botanic Gardens, Inc.
|
| Vol #:
|
| 85
|
|
|
| LET
11246
|
| Intelligent Nutrients, Inc.
|
| Vol #:
|
| 86
|
|
|
| 1998N-1109
|
| Mercury Compounds in Drugs and Food
|
|
|
| EC 3
|
| Renninger, Pamela
|
| Vol #:
|
| 2
|
|
|
| 2002N-0276
|
| Bioterrorism Preparedness;Registration of Food Facilities
|
|
|
| NIR
1
|
| FDA
|
| Vol #:
|
| 14
|
|
|
| 2002N-0278
|
| Bioterrorism; Prior Notice of Imported Food Shipments
|
|
|
| NIR
1
|
| FDA
|
| Vol #:
|
| 16
|
|
|
| 2003M-0443
|
| Premarket Approval, BP 010009/0, Cambridge Biotech HIV-1 Urine Western Blot
|
|
| AAV
1
SS&E,
Label
|
| Calypte Biomedical Corporation
|
| Vol #:
|
| 1
|
|
|
| 2003M-0444
|
| Premarket Approval, BP 010001/0, NucliSens HIV-1 QT
|
|
|
| AAV
1
SS&E,
Label
|
| bioMerieux, Inc
|
| Vol #:
|
| 1
|
|
|
| 2003M-0445
|
| Premarket Approval, BP 000028/0, The VERSANT HIV-1 RNA 3.0 Assay (bDNA)
|
|
|
| AAV
1
SS&E
|
| Bayer Corporation
|
| Vol #:
|
| 1
|
|
| | | | | | | | |
|
|
| 2003M-0446
|
| Premarket Approval, BP 010047/0, OraQuick Rapid HIV-1 Antibody Test
|
|
|
| AAV
1
SS&E,
Label
|
| OraSure Technologies, Inc
|
| Vol #:
|
| 1
|
|
|
| 2003M-0447
|
| Premarket Approval, BP-020066/0, Vironstika HIV-1 Plus O Microelisa System
|
|
|
| AAV
1
SS&E,
Label
|
| bioMerieux, Inc.
|
| Vol #:
|
| 1
|
|
|
| 2003N-0076
|
| Food Labeling: Trans Fatty Acids in Nutrition Labeling; Consumer research to consider possible footnote statements
|
|
|
| C
3
|
| American Bakers Association
|
| Vol #:
|
| 2
|
|
|
| C
4
|
| Golden Foods LLC, Golden Brands, LLC
|
| Vol #:
|
| 2
|
|
|
| C
5
|
| National Food Processors Association
|
| Vol #:
|
| 2
|
|
|
| C
6
|
| Chocolate Manufacturers Association, National Confectioners Association
|
| Vol #:
|
| 2
|
|
|
| C
7
|
| Institute of Shortening and Edible Oils, Inc.
|
| Vol #:
|
| 2
|
|
|
| EC 1
|
| Wilkinson, Leah
|
| Vol #:
|
| 1
|
|
|
| EC 2
|
| Freeman, Robbin
|
| Vol #:
|
| 2
|
|
|
| EC 3
|
| Joseph, Stephen
|
| Vol #:
|
| 1
|
|
|
| EC 4
|
| Clark, Donald
|
| Vol #:
|
| 1
|
|
|
| EC 5
|
| Black, Richard
|
| Vol #:
|
| 1
|
|
|
| EMC 53
|
| Sean
|
| Vol #:
|
| 1
|
|
|
| EMC 54
|
| Jodi Marvin
|
| Vol #:
|
| 1
|
|
|
| EMC 55
|
| Jodi Marvin
|
| Vol #:
|
| 1
|
|
|
| EMC
56
|
| The Schwan Food Company
|
| Vol #:
|
| 1
|
|
|
| EMC 57
|
| Number not used
|
| Vol #:
|
| 1
|
|
|
| EMC 58
|
| Kevin Theroux
|
| Vol #:
|
| 1
|
|
|
| EMC 59
|
| Radpython
|
| Vol #:
|
| 1
|
|
|
| EMC 60
|
| Cindy and Gary Wilson
|
| Vol #:
|
| 1
|
|
|
| EMC 61
|
| wings
|
| Vol #:
|
| 1
|
|
|
| EMC 62
|
| Richard Hormaza
|
| Vol #:
|
| 1
|
|
|
| EMC 63
|
| Louis Corcoran
|
| Vol #:
|
| 1
|
|
|
| EMC 64
|
| Roger and Teryl Parker
|
| Vol #:
|
| 1
|
|
|
| EMC 65
|
| M M Fullwood
|
| Vol #:
|
| 1
|
|
|
| EMC
66
|
| Conagra Foods
|
| Vol #:
|
| 1
|
|
|
| EMC 67
|
| Mary Starks
|
| Vol #:
|
| 1
|
|
|
| EMC 68
|
| Mike Baucom
|
| Vol #:
|
| 1
|
|
|
| EMC
69
Attachment
|
| American Dietetic Association
|
| Vol #:
|
| 1
|
|
|
| EMC
70
|
| Snack Food Association
|
| Vol #:
|
| 1
|
|
|
| EMC
71
|
| BanTransFats.com
|
| Vol #:
|
| 2
|
|
|
| EMC 72
|
| Stepan Company
|
| Vol #:
|
| 2
|
|
| | | | | | | | |
|
|
| EMC 73
|
| Diana Schneider
|
| Vol #:
|
| 2
|
|
|
| EMC
74
Attachment 1,
2
|
| Federal Trade Commission
|
| Vol #:
|
| 2
|
|
|
| EMC
75
|
| Grocery Manufacturers of America
|
| Vol #:
|
| 2
|
|
|
| EMC 76
|
| John Vance
|
| Vol #:
|
| 3
|
|
|
| EMC
77
|
| General Mills
|
| Vol #:
|
| 3
|
|
|
| EMC
78
|
| BanTransFats.com
|
| Vol #:
|
| 3
|
|
|
| EMC 79
|
| Lori
|
| Vol #:
|
| 3
|
|
|
| EMC 80
|
| Lorraine Warren
|
| Vol #:
|
| 3
|
|
|
| EMC 81
|
| Sandy Varndell
|
| Vol #:
|
| 3
|
|
|
| EMC 82
|
| Sandy Varndell
|
| Vol #:
|
| 3
|
|
|
| EMC 83
|
| Eric Varndell, Sandy Varndell, Savannah Varndell, Clara Varndell
|
| Vol #:
|
| 3
|
|
|
| EMC 84
|
| Laila Selk
|
| Vol #:
|
| 3
|
|
|
| EMC
85
|
| ILSI North America
|
| Vol #:
|
| 3
|
|
|
| EMC 86
|
| Earl R Green, 1SG US Army (Ret)
|
| Vol #:
|
| 3
|
|
|
| 2003N-0361
|
| Anti-Counterfeit Drug Initiative
|
|
|
| EC 3
|
| Alperin, Jay
|
| Vol #:
|
| 2
|
|
|
| EC 4
|
| Robertson, Michael
|
| Vol #:
|
| 2
|
|
|
| 2003N-0467
|
| Risk Assessment for Food Terrorism and Other Food Safety Concerns; Availability
|
|
|
| N
1
|
| FDA
|
| Vol #:
|
| 1
|
|
|
| RA 1
|
| BACKGROUND
|
| Vol #:
|
| 1
|
|
|
| 2003P-0475
|
| Drug Product containing hydrocodone bitartrate 5 mg and acetaminophen 325 mg in liquid form oral administration is suitable for evaluation under an ANDA
|
|
|
| ACK
1
|
| HFA-305 to Internationa Regulatory Business Consultants, L.L.C.
|
| Vol #:
|
| 1
|
|
|
| CP
1
Attachment
1, 2, 3,
4, 5
|
| International Regulatory Business Consultants, Ltd.
|
| Vol #:
|
| 1
|
|
|
| 2003P-0477
|
| Expedite the revocation of determination of the application of the AIP
|
|
|
| ACK 1
|
| HFA-305 to ENDOTEC
|
| Vol #:
|
| 1
|
|
|
| CP
1
Attachment
A, B,
C,
D,
E, F
|
| Endotec
|
| Vol #:
|
| 1
|
|
|
| 2003V-0473
|
| Variance Laser Display Device, JENOPTIK LOS: JenLas WHiteLight; Projector
|
|
|
| ACK 1
|
| HFA-305 to Carl Zeiss Jena GMBH
|
| Vol #:
|
| 1
|
|
|
| VAR 1
|
| Carl Zeiss Jena GMBH
|
| Vol #:
|
| 1
|
|
|